← FDA Medical Device Classifications
Intracranial Neurovascular Stent
NJE
· f · Unknown
Classification
FDA Product Code
NJE
Device class
f
Regulation
—
Review panel
NE
Medical specialty
Unknown
Submission type
6
GMP exempt
N
Life sustaining
N
Implant
Y
Third-party review
N
Definition
An intracranial neurovascular stent is a tubular device placed in the blood vessel of the intracranial cavity to treat a vascular abnormality. It differs from other stents in that it is intended for intracranial use.
Market data
Cleared 510(k) submissions
0
Registered establishments
16
Source
Authoritative
FDA Device Classification database
Machine
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